Services
Regulatory Affairs
Promotional Materials Review
Promotional Materials Review
Regulatory Affairs guidance, creation and filing of all types of submissions for drugs and medical devices in Canada including:
- Regulatory Filing Strategy
- Due Diligence and Regulatory Gap Analysis
- Pre-submission meetings with Health Canada (TPD and BGTD)
- Preparation of Submissions: New Drug Submissions (NDS & ANDS), Supplemental New Drug Submissions (SNDS &ASNDS), Notifiable Changes (NC), Annual Notifications, Annual DIN Renewals, Drug Identification Number (DINs)
- Label Negotiations with Health Canada
- Clinical Trial Applications for drugs and Medical Devices
- CPP and CEP
- Label Creation and Review ( pre and post approval)
- Medical Cannabis Licence Applications, Amendments and Notifications
Promotional Materials Review
Promotional Materials Review
Promotional Materials Review
- Review of advertising (Patient/Healthcare) and promotional materials (digital, print, sales detail aids) to ensure compliance to Canadian advertising regulations and PAAB guidelines
Quality Operations
Promotional Materials Review
Quality Operations
- Creation and review of GMP SOP’s
- Drug Establishment Licence (DEL) and Medical Device Establishment Licence (MDEL) applications and submissions
- Assistance with and Hosting of Health Canada GMP Audits
- GMP Compliance Gap Analysis
- Production Records Review and Product Release for Canadian Market
- Distribution channels' alignment with Canadian GMP guidelines
- Creation of Quality Agreements with suppliers and third party logistics vendors
- Inspection readiness training (On-Site Evaluation by BGTD and routine GMP inspections)